IMMULITE 2000 Anti-TG Ab Catalog # L2KTG6 (600 Tests), SMN 10381655, System, Test, Thyroid Autoantibody.
Siemens Healthcare Diagnostics, Inc. · The potential for falsely elevated patient sample results when using impacted lots (785, 790, 791, and 793) of IMMULITE 2000 Anti-TG Ab.
Open FDA's page for this record- Cfres ID
- 207317
- Product res number
- Z-1887-2024
- Event date initiated
- 2024-04-23
- Event date posted
- 2024-05-23
- Recall status
- Open, Classified
- Res event number
- 94495
- Product code
- JZO
- Product description
- IMMULITE 2000 Anti-TG Ab Catalog # L2KTG6 (600 Tests), SMN 10381655, System, Test, Thyroid Autoantibody.
- Code info
- Catalog # L2KTG6, SMN 10381655, UDI/DI: 00630414962115, Lot #s: 785, 790, 791, 793.
- Firm FEI number
- 1219913
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Address 1
- 333 Coney St
- City
- East Walpole
- State
- MA
- Postal code
- 02032-1516
- Additional info contact
- Jennifer Cacace 802-430-2902
- Reason for recall
- The potential for falsely elevated patient sample results when using impacted lots (785, 790, 791, and 793) of IMMULITE 2000 Anti-TG Ab.
- Root cause description
- Under Investigation by firm
- Product quantity
- 488 units (33 US, 455 OUS)
- Action
On April23, 2024, Urgent Medical Device Correction letters were sent to customers. Customer Actions: 1. Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. 2. Perform the following: Discontinue use of and discard the kit lots listed in the Products Table. You may request no-charge replacement product from your local Siemens Healthineers or distributor office. Please review your inventory of these products to determine your laboratory s replacement needs and to provide information to Siemens Healthineers for reporting to the authorities. Complete and return the Field Correction Effectiveness Check and indicate product replacement needs on the form attached to this letter within 30 days. Please retain this letter with your laboratory records and forward this letter to those who may have received this product.
- Distribution pattern
Worldwide - US Nationwide distribution including in the states of AL, CA, DC, FL, HI, ID, IN, KS, KY MA, MI, MN, MO, NC, NJ, NY, OH, OR, PA, PR, TX, WA WI and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Ecuador, Finland, France, Germany, Greece Guatemala, Honduras, Hong Kong, Hungary, Hungary, India, Iran, Ireland, Israel, Italy, Kazakhstan, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mexico, Netherlands, Norway, P.R. China, Pakistan, Paraguay, Peru, Poland, Portugal, Republic South Korea, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Taiwan, Tunisia, Turkey, Turkmenistan, Ukraine, United Kingdom, Uruguay, Vietnam.
- K numbers
- K991094
- Harmonized identifiers (openFDA)
- Device name
- System, Test, Thyroid Autoantibody
- Medical specialty description
- Immunology
- Regulation number
- 866.5870
- Device class
- 2
- K number
- K051890, K980206, K841580, K952129, K991096, K950088, K925923, K950089, K810982, K011415, K020687, K193313, K915428, K984228, K003291, K011082, K981559, K020348, K020349, K222610, K894203, K213517, K152061, K960369, K871193, K984163, K905485, K000286, K951487, K151799, K080159, K963695, K981930, K821489, K061382, K981522, K992790, K033454, K993585, K023593 +52 more
- Registration number
- 2090110, 9612316, 3006198300, 3011989923, 2432235, 2242436, 2915274, 8043792, 2032839, 3002806944, 8031673, 3005529799, 1181121, 9680746, 1421346, 3003834021, 3033967997, 1036362, 3008344661, 9610566, 8023018, 1219913, 2245285, 3007208259, 2122870, 2029372, 2025560, 9610126, 3004973408, 3005333358, 3002800697, 1528450, 3039353646, 8020888, 3002809144
- FEI number
- 3006198300, 3011989923, 2432235, 2967, 2242436, 1000122536, 2915274, 3002808269, 3002807272, 3002806944, 3002807876, 3005529799, 1181121, 1421346, 1000306617, 1000206808, 3033967997, 3002346973, 1036362, 3002806559, 3008344661, 1219913, 2245285, 3007019572, 3007208259, 2122870, 2025560, 3004185580, 3004973408, 3002808328, 3005333358, 3002800697, 3002808039, 3039353646, 3002809144